Study on the Efficacy and Safety of MA-BUCY2 Conditioning in High-risk AML Patients Underwent Haplo-HSCT

NCT ID: NCT05814731

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-15
• Study Completion Date: 2025-12-31

Brief Summary

According to the 2022 ELN guidelines patients with high-risk acute myeloid leukemia were randomly divided into MA-BUCY2 conditioning group and BuCy2 conditioning group，to evaluate the efficacy and safety of two conditioning regimens in haploidentical hematopoietic stem cell transplantation.

Detailed Description

High risk acute myeloid leukemia patients were randomly divided into two groups before conditioning of haploidentical hematopoietic stem cell transplantation.The control group will use the BUCY2 conditioning，and the experimental group will use mitoxantrone liposome combined with BUCY2 for conditioning. After transplantation，we will observe the difference of one year relapse rates between two goups，also the adverse reactions of conditioning，GVHD，OS and PFS of the patients in two groups also been observed.

Conditions

Haploidentical Stem Cell Transplantation; Conditioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MA-BUCY2

Mitoxantrone liposome 20mg/m2，ivgtt，d-11 ；Ara-C 4g/m2.d ，ivgtt，d-10- -9； BU 0.8 mg/kg q6h，ivgtt，d-8- -6； CTX 1.8 g/m2.d ，ivgtt，d-5- -4； me-CCNU 250 mg/m2，p.o，d-3； ATG 2.5 mg/Kg.d，d-5 -2；

Group Type: EXPERIMENTAL

MA-BUCY2

Intervention Type: DRUG

Mitoxantrone liposome 20mg/m2，ivgtt，d-11 ；Ara-C 4g/m2.d ，ivgtt，d-10- -9； BU 0.8 mg/kg q6h，ivgtt，d-8- -6； CTX 1.8 g/m2.d ，ivgtt，d-5- -4； me-CCNU 250 mg/m2，p.o，d-3； ATG 2.5 mg/Kg.d，d-5 -2

BUCY2

Ara-C 4g/m2.d ，ivgtt，d-10- -9； BU 0.8 mg/kg q6h，ivgtt，d-8- -6； CTX 1.8 g/m2.d ，ivgtt，d-5- -4； me-CCNU 250 mg/m2，p.o，d-3； ATG 2.5 mg/Kg.d，d-5 -2；

Group Type: ACTIVE_COMPARATOR

BUCY2

Intervention Type: DRUG

Ara-C 4g/m2.d ，ivgtt，d-10- -9； BU 0.8 mg/kg q6h，ivgtt，d-8- -6； CTX 1.8 g/m2.d ，ivgtt，d-5- -4； me-CCNU 250 mg/m2，p.o，d-3； ATG 2.5 mg/Kg.d，d-5 -2

Interventions

MA-BUCY2

Mitoxantrone liposome 20mg/m2，ivgtt，d-11 ；Ara-C 4g/m2.d ，ivgtt，d-10- -9； BU 0.8 mg/kg q6h，ivgtt，d-8- -6； CTX 1.8 g/m2.d ，ivgtt，d-5- -4； me-CCNU 250 mg/m2，p.o，d-3； ATG 2.5 mg/Kg.d，d-5 -2

Intervention Type: DRUG

BUCY2

Ara-C 4g/m2.d ，ivgtt，d-10- -9； BU 0.8 mg/kg q6h，ivgtt，d-8- -6； CTX 1.8 g/m2.d ，ivgtt，d-5- -4； me-CCNU 250 mg/m2，p.o，d-3； ATG 2.5 mg/Kg.d，d-5 -2

Intervention Type: DRUG

Other Intervention Names

Mitoxantrone liposome; cytarabine; busulfan; cyclophosphamide; semustine; anti-thymocyte immunoglobulin; Cytarabine; busulfan; cyclophosphamide; semustine; anti-thymocyte immunoglobulin

Eligibility Criteria

Inclusion Criteria

• Meet the diagnostic criteria of 2022 ELN guidelines for high-risk acute myeloid leukemia;
• Patients with allogeneic stem cell transplantation indications;
• Age 18-60 (including upper and lower limits) ;
• No gender limit;
• ECOG score 0~2 points;
• Flow MRD was negative before transplantation;
• The organ function level must meet the following requirements: a) Liver: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal value (ULN), Total bilirubin (TBIL) ≤ 1.5 × ULN； b) Kidney: blood creatinine ≤ 1.5 × ULN； c) Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN； d) Normal cardiac function: that is, the ECG is normal or abnormal without clinical significance, and the left ventricular ejection fraction (LVEF) is greater than 60 or myocardial zymogram CK-MB is normal, pro-BNP is less than 900 pg/ml;
• The results of serum pregnancy test of female subjects with reproductive ability must be negative before the first use of the test drug;

Exclusion Criteria

• Previously received doxorubicin or other anthracycline drugs, and the total cumulative dose of doxorubicin was more than 360 mg/m2;
• Hypersensitivity to any study drug or its components;
• Cardiac function and disease meet one of the following conditions:

1. Long QTc syndrome or QTc interval>480 ms;

2. Complete left bundle branch block, II or III degree atrioventricular block;

3. Serious and uncontrolled arrhythmia requiring drug treatment;

4. American New York Heart Association rating ≥ III;

5. Cardiac ejection fraction (LVEF) is less than 60%;

6. History of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or He has any arrhythmia requiring treatment, clinical history of serious pericardial disease, or acute ischemia or activity ECG evidence of abnormal conduction system.;\

• Active infection of hepatitis B and hepatitis C;
• Human immunodeficiency virus (HIV) infection;
• Patients with other malignant tumors;
• Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
• Have a history of abuse of drugs;
• History of mental illness or cognitive impairment; .Other researchers judged that it was not suitable for this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoning Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

xiaonig wang, M.D.

Role: CONTACT

wangxn99@163.com

0086-18991232608

Facility Contacts

Xiaoning Wang, MD

Role: primary

wangxn99@163.com

0086-18991232608

Xiaoyan Zheng, MD

Role: backup

xiaoy_2008@163.com

0086-15829370502

Other Identifiers

XJTU1AF2022SJ-XK005

Identifier Type: -

Identifier Source: org_study_id